Biosimilar Interchangeability and Extrapolation - Booklet
Review key information about how biosimilars and interchangeable biosimilars are approved by the FDA and the associated requirements.
What you'll learn:
- How similarity to a reference product is demonstrated using the ‘totality-of-evidence’ approach.
- Definition of extrapolation, including the parameters for meeting sufficient scientific justification for extrapolating data.
- Definition of an interchangeable biosimilar.
- The regulatory requirements for interchangeability that often include clinical studies, known as switching studies.
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A short animated video outlining BI’s commitment to biologics and biosimilars.
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